Office Action Predictor
Last updated: April 15, 2026
Application No. 18/297,133

CONTAINER FOR AN INJECTABLE MEDICAMENT

Non-Final OA §103
Filed
Apr 07, 2023
Examiner
DIPERT, FORREST BLAKE
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Sanofi
OA Round
1 (Non-Final)
46%
Grant Probability
Moderate
1-2
OA Rounds
3y 6m
To Grant
99%
With Interview

Examiner Intelligence

Grants 46% of resolved cases
46%
Career Allow Rate
16 granted / 35 resolved
-24.3% vs TC avg
Strong +67% interview lift
Without
With
+66.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
53 currently pending
Career history
88
Total Applications
across all art units

Statute-Specific Performance

§101
0.8%
-39.2% vs TC avg
§103
48.2%
+8.2% vs TC avg
§102
27.2%
-12.8% vs TC avg
§112
21.8%
-18.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 35 resolved cases

Office Action

§103
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Information Disclosure Statement The information disclosure statement(s) have been considered by the examiner. Priority Priority to the application PCT/EP2019/051551, US 16964701, EP 18305065.7 has been acknowledged. Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claim 1-2, 4-6, 8, 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190054252 A1, henceforth written as Amschler, in view of US 20070193350 A1, henceforth written as Nishizu. Regarding Claim 1 Amschler discloses: An injection device comprising: (medicine delivery device 800; fig 8) a medicament container; (cartridge 810; fig 8) a signal generator configured transmit one or more signals towards the medicament container, (paragraph 72-77; transmitter (not enumerated/illustrated) of ultrasonic transceiver 850; fig 8) the one or more signals configured to excite one or more resonances of the medicament container; Examiner notes claim language of “configured to” implies a functional language and the prior art must at least be capable of performing the recited function exciting one or more resonances in the medicament container. As disclosed by in paragraph 65-66 of Amschler, an emitted ultrasonic wave signal, such as the ultrasonic signal emitted in the embodiment of paragraph 72-77 and fig 8, can interfere with the reflected signal such an acoustic resonance is excited within the cavity of the container. Thus, the ultrasonic signal emitted by Amschler's transceiver 850 is functionally capable of exciting a resonance of cartridge 810. a signal detector configured to measure [the one or more signals transmitted by] the signal generator while the signal generator transmits the one or more signals; and (paragraph 72-77; receiver (not enumerated/illustrated) of ultrasonic transceiver 850 receives the ultrasonic signal transmitted by the transmitter of transceiver 850 while the transmitter is emitting the signal; fig 8) a processor configured to determine one or more properties of the medicament container based on the measured one or more [signals transmitted by the signal generator]. (paragraph 72-77; processing circuitry (not enumerated/illustrated) of the receiver of the ultrasonic transceiver 850 determines round trip delay/time of flight based on the detected and transmitted signals, therein a time varying voltage/current of electronic information representing the waveform emitted from transceiver 850's transmitter, which is leveraged to determine a length of the cavity, therein a property of, of cartridge 810) Amschler discloses the elements of the present claim, as described above. Yet, its present embodiment is silent regarding the precise type of signal/unit of measurement measured by the signal detector and examined by the processor for determining a property of the medicament container being that of a voltage or current: However Nishizu teaches a processing system of invention which determines a resonant frequency of an acoustic cavity system wherein: the system determines one or more properties of the medicament container based on the measured one or more voltages or currents (paragraph 28-29+98-100+110-111+143; the voltage signal from the signal generator, coil of speaker 2, is analyzed with respect to the frequency spectrum of the emitted signal to determine a resonant frequency of the acoustic system) Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply Nishizu’s teachings of analyzing the voltage signal from its transmitter to determine when an acoustic system has reached acoustic resonance to the modified device of Amschler, by replacing Amschler’s transmitter with Nishizu’s speaker 2 such that Amschler’s transceiver 850’s processing circuitry can incorporate the processing teaching of Nishizu to measure the voltage signal from Nishizu’s speaker 2, in order to advantageously arrive at an invention which applies a known technique of utilizing voltage measurements of transmitted signals to make determinations about an acoustic cavity’s properties based on those voltage measurements to a similar known device which relies on measuring signals from an ultrasonic transmitter to make a determination of cavity length, see MPEP 2143(i)(d). Regarding claim 2, Amschler discloses: The injection device of claim 1, wherein at least one of the signal generator, the signal detector, or the processor is disposed in or on a bung of the medicament container. (paragraph 75, "ultrasonic transceiver 850 located in dispensing piston 820 or shaft 830") Regarding claim 4, the modified device of Amschler in view of Nishizu discloses: The injection device of claim 1, wherein the one or more properties include at least one of a size of an interior volume of the medicament container or a position of a bung within the medicament container. Amschler: (paragraph 72-77; processing circuitry (not enumerated/illustrated) of ultrasonic transceiver 850 determines length of the cavity, therein a size of an interior volume and a relative position of piston820/shaft830 inside, of cartridge 810 based on the detected and transmitted signals) Regarding Claim 5, Amschler discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Amschler’s present embodiment is silent regarding: The injection device of claim 4, wherein the processor is configured to determine the one or more properties based on – frequency -- of the measured one or more voltages or currents. Notably, Amschler teaches an alternative embodiment for determining a cavity’s length in paragraph 64-71 with a resonant frequency based measurement where upon detecting that the transmitted ultrasonic signal have elicited a resonant condition in the cavity, the “frequency of the transmitted ultrasonic signals at the resonant condition may then be used to determine the length of the resonant cavity”. Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate Amschler’s alternative means of determining a cavity’s length using a resonant frequency based measurement to Amschler’s disclosed invention of fig 8, in order to advantageously arrive at an invention with multiple redundant means for determining a length of a cavity of a drug container and thus improve the reliability of the invention against failure modes limiting the efficacy of a single one of the measurement means, such as failure to receive/measure a reflected acoustic wave. However, the presently modified device of Amschler remains silent as to the exact processing which determines that the resonant condition has occurred based on the transmitted signal, and thus is silent regarding the processor configuration of the present claim. Notably, Nishizu teaches a processing system of invention which determines a resonant frequency of an acoustic cavity system wherein: the processor is configured to determine the one or more properties based on one or more positive or negative frequency-dependent peaks of the measured one or more voltages or currents. (paragraph 28-29+98-100+110-111+143; the peak of the voltage signal from the signal generator, coil of speaker 2 along the frequency-voltage spectrum occurs at the resonant frequency of the acoustic system as the oscillation created by speaker 2) Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply Nishizu’s teachings of analyzing the voltage signal from its transmitter for a peak value to determine when an acoustic system has reached acoustic resonance to the modified device of Amschler, by replacing Amschler’s transmitter with Nishizu’s speaker 2 such that Amschler’s transceiver 850’s processing circuitry can incorporate the processing teaching of Nishizu to measure the voltage signal from Nishizu’s speaker 2 and determine when the emitted signal has moved Amschler’s device 800 into a resonant condition, in order to advantageously arrive at an invention which applies a known technique of identifying resonant conditions based on a transmitted signal to a similar known device which relies on detecting that resonant condition to make a determination of cavity length, see MPEP 2143(i)(d). Regarding claim 6, the modified device of Amschler in view of Nishizu teaches: The injection device of claim 5, wherein one or more frequencies of the one or more positive or negative frequency-dependent peaks is indicative of one or more frequencies of the one or more resonances of the medicament container. Examiner notes that in light of the modification made in claim 5 above, the frequency of the voltage peak detected by Nishizu's teachings is indicative of the Amschler's medicament container reaching a resonant state. Regarding claim 8, the modified device of Amschler in view of Nishizu discloses: The injection device of claim 1, wherein the signal detector is configured to measure the one or more voltages or currents of the signal generator at each frequency of the one or more signals while the signal generator transmits the one or more signals. (Examiner notes in light of the combination of Amschler in view of Nishizu in claim 1 above, the receiver (not enumerated/illustrated) of ultrasonic transceiver 850 measures the voltages of the claimed signal generator relative to the frequency spectrum of the transmitted signal. Further consider paragraph 76 of Amschler notes that that the invention is operable with multiple frequency bands, therein the claimed signal detector is measures the voltage of the signal of the claimed signal generator at the frequency which the signal generator transmits the signal at) Regarding Claim 11, Amschler discloses: A medicament container comprising: (cartridge 810; fig 8) a signal generator configured transmit one or more signals towards the medicament container, (paragraph 72-77; transmitter (not enumerated/illustrated) of ultrasonic transceiver 850; fig 8) the one or more signals configured to excite one or more resonances of the medicament container; and Examiner notes claim language of “configured to” implies a functional language and the prior art must at least be capable of performing the recited function exciting one or more resonances in the medicament container. As disclosed by in paragraph 65-66 of Amschler, an emitted ultrasonic wave signal, such as the ultrasonic signal emitted in the embodiment of paragraph 72-77 and fig 8, can interfere with the reflected signal such an acoustic resonance is excited within the cavity of the container. Thus, the ultrasonic signal emitted by Amschler's transceiver 850 is functionally capable of exciting a resonance of cartridge 810. a signal detector configured to measure one or more [signals transmitted by] the signal generator while the signal generator transmits the one or more signals, -- (paragraph 72-77; receiver (not enumerated/illustrated) of ultrasonic transceiver 850 receives the ultrasonic signal transmitted by the transmitter of transceiver 850 while the transmitter is emitting the signal; fig 8) Amschler discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on: the measured one or more [signals] being indicative of one or more frequencies of the one or more resonances of the medicament container Notably, Amschler teaches an alternative embodiment for determining a cavity’s length in paragraph 64-71 with a resonant frequency based measurement where upon detecting that the transmitted ultrasonic signal had elicited a resonant condition in the cavity, the “frequency of the transmitted ultrasonic signals at the resonant condition may then be used to determine the length of the resonant cavity”. Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate Amschler’s alternative means of determining a cavity’s length using a resonant frequency based measurement to Amschler’s disclosed invention of fig 8, in order to advantageously arrive at an invention with multiple redundant means for determining a length of a cavity of a drug container and thus improve the reliability of the invention against failure modes limiting the efficacy of a single one of the measurement means, such as failure to receive/measure a reflected acoustic wave. The modified device of Amschler discloses the elements of the present claim, as described above. Yet, its present embodiment is silent regarding the precise type of signal/unit of measurement measured by the signal detector and examined by the processor for determining a property of the medicament container being that of a voltage or current: However Nishizu teaches a processing system of invention which determines a resonant frequency of an acoustic cavity system wherein: the system determines one or more properties of the medicament container based on the measured one or more voltages or currents (paragraph 28-29+98-100+110-111+143; the voltage signal from the signal generator, coil of speaker 2, is analyzed with respect to the frequency spectrum of the emitted signal to determine a resonant frequency of the acoustic system) Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply Nishizu’s teachings of analyzing the voltage signal from its transmitter for a peak value to determine when an acoustic system has reached acoustic resonance to the modified device of Amschler, by replacing Amschler’s transmitter with Nishizu’s speaker 2 such that Amschler’s transceiver 850’s processing circuitry can incorporate the processing teaching of Nishizu to measure the voltage signal from Nishizu’s speaker 2 and determine when the emitted signal has moved Amschler’s device 800 into a resonant condition, in order to advantageously arrive at an invention which applies a known technique of identifying resonant conditions based on a transmitted signal to a similar known device which relies on detecting that resonant condition to make a determination of cavity length, see MPEP 2143(i)(d). Regarding claim 12, the modified device of Amschler in view of Nishizu discloses: The medicament container of claim 11, further comprising a processor configured to determine one or more properties based on the measured one or more voltages or currents. (Examiner notes in light of the combination of Amschler in view of Nishizu above that the processing circuitry (not enumerated/illustrated) of Amschler utilizes Nishizu’s teachings of measuring a voltage of the signal transmitted by the claimed signal generator to determine a resonance of the invention’s acoustic cavity based on this measured voltage signal) Regarding claim 13, the modified device of Amschler in view of Nishizu discloses: The medicament container of claim 12, wherein at least one of the signal generator, the signal detector, or the processor is disposed in or on a bung of the medicament container. Amschler: (paragraph 75, "ultrasonic transceiver 850 located in dispensing piston 820 or shaft 830") Regarding claim 14, the modified device of Amschler in view of Nishizu discloses: The medicament container of claim 12, wherein the one or more properties include at least one of a size of an interior volume of the medicament container or a position of a bung within the medicament container. Amschler: (paragraph 72-77; processing circuitry (not enumerated/illustrated) of ultrasonic transceiver 850 determines length of the cavity, therein a size of an interior volume and a relative position of piston820/shaft830 inside, of cartridge 810 based on the detected and transmitted signals) Regarding Claim 15, The modified device of Amschler discloses all of the elements of the current invention which the present claim is dependent upon, as described above. Notably, the presently modified device of Amschler remains silent as to the exact processing which determines that the resonant condition has occurred based on the transmitted signal, and thus, the modified device of Amschler is silent regarding: The injection device of claim 12, wherein the processor is configured to determine the one or more properties based on one or more positive or negative frequency-dependent peaks of the measured one or more voltages or currents. Notably, Nishizu teaches a processing system of invention which determines a resonant frequency of an acoustic cavity system wherein: the processor is configured to determine the one or more properties based on one or more positive or negative frequency-dependent peaks of the measured one or more voltages or currents. (paragraph 28-29+98-100+110-111+143; the peak of the voltage signal from the signal generator, coil of speaker 2, along the frequency-voltage spectrum occurs at the resonant frequency of the acoustic system created by speaker 2; fig 1+5) Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply Nishizu’s teachings of analyzing the voltage signal from its transmitter for a peak value to determine when an acoustic system has reached acoustic resonance to the modified device of Amschler, by replacing Amschler’s transmitter with Nishizu’s speaker 2 such that Amschler’s transceiver 850’s processing circuitry can incorporate the processing teaching of Nishizu to measure the voltage signal from Nishizu’s speaker 2 and determine when the emitted signal has moved Amschler’s device 800 into a resonant condition, in order to advantageously arrive at an invention which applies a known technique of identifying resonant conditions based on a transmitted signal to a similar known device which relies on detecting that resonant condition to make a determination of cavity length, see MPEP 2143(i)(d). Regarding claim 16, the modified device of Amschler in view of Nishizu discloses: The medicament container of claim 15, wherein one or more frequencies of the one or more positive or negative frequency-dependent peaks is indicative of one or more frequencies of the one or more resonances of the medicament container. Examiner notes that in light of the modification made in claim 15 above, the frequency of the voltage peak detected by Nishizu's teachings is indicative of the Amschler's medicament container reaching a resonant state. Regarding Claim 17, Amschler discloses: A method comprising: (invention of fig 8) transmitting, by a signal generator, one or more signals towards (paragraph 72-77; transmitter (not enumerated/illustrated) of ultrasonic transceiver 850; fig 8) a medicament container -- (cartridge 810; fig 8) while the signal generator transmits the one or more signals, measuring, by a signal detector, [the one or more signal transmitted by] the signal generator; and (paragraph 72-77; receiver (not enumerated/illustrated) of ultrasonic transceiver 850 receives the ultrasonic signal transmitted by the transmitter of transceiver 850 while the transmitter is emitting the signal; fig 8) determining, by a processor, one or more properties of the medicament container based on the measured one or more [signals transmitted by the signal generator]. (paragraph 72-77; processing circuitry (not enumerated/illustrated) of the receiver of the ultrasonic transceiver 850 determines round trip delay/time of flight based on the detected and transmitted signals, therein a time varying voltage/current of electronic information representing the waveform emitted from transceiver 850's transmitter, which is leveraged to determine a length of the cavity, therein a property of, of cartridge 810) Amschler discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on: transmitting -- one or more signals towards a medicament container to excite one or more resonances of the medicament container Notably, Amschler teaches an alternative embodiment for determining a cavity’s length in paragraph 64-71 with a resonant frequency based measurement where upon detecting that the transmitted ultrasonic signal had elicited a resonant condition in the cavity, the “frequency of the transmitted ultrasonic signals at the resonant condition may then be used to determine the length of the resonant cavity”. Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate Amschler’s alternative means of determining a cavity’s length using a resonant frequency based measurement to Amschler’s disclosed method of operating its invention of fig 8, in order to advantageously arrive at an invention with multiple redundant means for determining a length of a cavity of a drug container and thus improve the reliability of the invention against failure modes limiting the efficacy of a single one of the measurement means, such as failure to receive/measure a reflected acoustic wave. The modified device of Amschler discloses the elements of the present claim, as described above. Yet, its present embodiment is silent regarding the precise type of signal/unit of measurement measured by the signal detector and examined by the processor for determining a property of the medicament container being that of a voltage or current: However Nishizu teaches a processing system of invention which determines a resonant frequency of an acoustic cavity system wherein: the system determines one or more properties of the medicament container based on the measured one or more voltages or currents (paragraph 28-29+98-100+110-111+143; the voltage signal from the signal generator, coil of speaker 2, is analyzed with respect to the frequency spectrum of the emitted signal to determine a resonant frequency of the acoustic system) Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply Nishizu’s teachings of analyzing the voltage signal from its transmitter for a peak value to determine when an acoustic system has reached acoustic resonance to the modified device of Amschler, by replacing Amschler’s transmitter with Nishizu’s speaker 2 such that Amschler’s transceiver 850’s processing circuitry can incorporate the processing teaching of Nishizu to measure the voltage signal from Nishizu’s speaker 2 and determine when the emitted signal has moved Amschler’s device 800 into a resonant condition, in order to advantageously arrive at an invention which applies a known technique of identifying resonant conditions based on a transmitted signal to a similar known device which relies on detecting that resonant condition to make a determination of cavity length, see MPEP 2143(i)(d). Regarding Claim 18, The modified method of Amschler in view of Nishizu teaches: The method of claim 17, wherein the one or more voltages or currents are measured at each frequency of the one or more signals. Examiner notes that in light of the combination of Amschler in view of Nishizu made in claim 17 above, the signal detector and processing circuitry of Amschler performs Nishizu’s teachings in paragraph 28-29+98-100+110-111+143 and fig 5, of determining a resonant frequency based on the voltage-frequency spectrum of the signal, thus measuring the voltage of the signal at each frequency which the one or more signals are emitted at. Regarding Claim 19, The modified method of Amschler in view of Nishizu teaches: The method of claim 17, wherein determining the one or more properties comprises determining one or more positive or negative frequency-dependent peaks of the measured one or more voltages or currents. Examiner notes that in light of the combination of Amschler in view of Nishizu made in claim 17 above, the signal detector and processing circuitry of Amschler performs Nishizu’s teachings in paragraph 28-29+98-100+110-111+143 and fig 5, of determining a resonant frequency based on the voltage-frequency spectrum, and particularly the frequency dependent peak of the signal, thus measuring the voltage of the signal at each frequency which the one or more signals are emitted at. Regarding claim 20, the modified method of Amschler in view of Nishizu discloses: The method of claim 19, wherein determining the one or more properties comprises: determining one or more frequencies of the positive or negative frequency-dependent peaks; and determining the one or more properties based on the one or more frequencies of the positive or negative frequency-dependent peaks. Examiner notes in view of the combination made in claim 19 above, the step of determining the property of the medicament container involves identifying the frequency by where the voltage of the signal from the signal generator is at a positive/negative peak. Claims 3 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Amschler in view of Nishizu, as applied to claims above, in view of US 10869967 B2 henceforth written as Sleicher. Regarding Claim 3, The modified device of over Amschler in view of Nishizu discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim: The injection device of claim 1, wherein the signal generator, the signal detector -- are disposed in or on a bung of the medicament container. Amschler: (paragraph 75, "ultrasonic transceiver 850 located in dispensing piston 820 or shaft 830") However, the modified device of Amschler in view of Nishizu is silent regarding: wherein the processor [is] disposed in or on a bung of the medicament container. However, Sleicher teaches a drug delivery device with a sensor system embedded in its bung, wherein in fig 7 it is illustrated and in col 8 line 34 to col 9 line 51 it is detailed that the sensitive electronics (i.e. transducer, sensor, power, processing circuitry, etc.) are embedded within stopper 700 and surrounded by a material which undergoes a phase change proximate to the temperature which the device is sterilized at in order to protect the electronics from excess heat energy present in the sterilization process which could overheat such sensitive electronics. Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply Sleicher’s teachings of disposing its sensitive electronics within its stopper of a specific material, to the sensitive electronics disclosed by the modified device of Amschler in view of Nishizu, thus disposing the claimed signal generator, claimed signal detector, and claimed processor within Amschler’s bung and forming Amschler’s bung from Sliecher’s phase change material, in order to advantageously arrive at an invention which protects its sensitive electronics from the sterilization process imposed on medical devices, see col 9 line 7-23 of Sleicher. Regarding Claim 9, The modified device of over Amschler in view of Nishizu discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim: The injection device of claim 1, further comprising a circuit board disposed in or on a bung of the medicament container, the circuit board comprising -- the signal generator, and the signal detector. Amschler: (paragraph 75, "ultrasonic transceiver 850 located in dispensing piston 820 or shaft 830"; the circuitry which enjoins the electronic elements of the ultrasonic transceiver 850, such as its transmitter and receiver, is considered the claimed circuit board because of the manner by which it connects electronic elements together to communicate signals therebetween) However, the modified device of Amschler in view of Nishizu is silent regarding: a circuit board disposed in or on a bung of the medicament container, the circuit board comprising a processor However, Sleicher teaches a drug delivery device with a sensor system embedded in its bung, wherein in fig 7 it is illustrated and in col 8 line 34 to col 9 line 51 it is detailed that the sensitive electronics (i.e. transducer, sensor, power, processing circuitry, etc.) are embedded within stopper 700 and surrounded by a material which undergoes a phase change proximate to the temperature which the device is sterilized at in order to protect the electronics from excess heat energy present in the sterilization process which could overheat such sensitive electronics. Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply Sleicher’s teachings of disposing its sensitive electronics within its stopper of a specific material, to the sensitive electronics disclosed by the modified device of Amschler in view of Nishizu, thus disposing the Amschler’s claimed circuit board and thus also its claimed signal generator, claimed signal detector, and claimed processor within Amschler’s bung and forming Amschler’s bung from Sliecher’s phase change material, in order to advantageously arrive at an invention which protects its sensitive electronics from the sterilization process imposed on medical devices, see col 9 line 7-23 of Sleicher. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Amschler in view of Nishizu, as applied to claim 6 above, in view of US 5780743 A, henceforth written as Morgan. Regarding Claim 7, The modified device of over Amschler in view of Nishizu discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim: The injection device of claim 6, wherein a -- frequency of the one or more frequencies of the one or more positive or negative frequency-dependent peaks is indicative of a [harmonic and ] fundamental resonance frequency of the medicament container Examiner notes that harmonic frequencies of a system are themselves indicative of the fundamental resonance frequency of that system as they are inherently a multiple of that fundamental frequency. Similarly, any harmonic resonant frequency is a harmonic multiple of the fundamental resonance frequency. Therein, the frequency measured by the processing teachings of Nishizu applied to the modified device of Amschler is indicative of both the harmonic resonance frequency and a fundamental frequency. However, the modified device of Amschler in view of Nishizu is silent regarding the processor measuring multiple harmonic frequencies to identify multiple positive or negative frequency-dependent peaks indicative of harmonic resonance and fundamental resonance frequencies of the one or more resonances of the medicament container. However, Morgan teaches an invention for determining a resonance condition in a fluid filled cylinder wherein in col 3 line 60 to col 4 line 48 and figure 3 it is taught that when the invention identifies multiple higher order harmonic frequencies, the first order harmonic frequency aka the fundamental resonant frequency may be identified and locked on to accurately calculate a resonant frequency by limiting the noise which is amplified in higher order resonant frequencies. Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply Morgan’s teachings of identifying multiple higher order harmonic frequencies to hone in on a base fundamental frequency for determining a resonant frequency of the system to the processing system disclosure of the modified device of Amschler in view of Nishizu, in order to advantageously arrive at an invention which “permits calculations that yield highly accurate resonance frequency values”, see col 4 line 31-32 of Morgan. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Amschler in view of Nishizu, as applied to claims above, in view of US 4285053 A, henceforth written as Kren. Regarding Claim 10, The modified device of Amschler in view of Nishizu discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Amschler in view of Nishizu is silent regarding: The injection device of claim 1, wherein the signal detector comprises an impedance measurement circuit comprising a diode, a capacitor, and an analog-to-digital converter electrically connected to a node between the diode and the capacitor. Examiner notes that the present embodiment of Amschler relies upon detecting a difference in a phase shift of an ultrasonic wave to determine time of flight of a transmitted acoustic wave to determine a length of its acoustic cavity, see paragraph 72-77, however, it does not recite the exact processing technique/structure which determines this phase shift to perform the consequent cavity length determination. However, Kren teaches a distance gauge which relies upon phase shifts in transmitted/received acoustic waves to determine a distance which great accuracy wherein the signal detector comprises an impedance measurement circuit (circuit (not enumerated) of fig 3, excluding oscillator 25 and wire 15, detects signals from the microphone 33 via the circuit’s wires 35 and from oscillator 25 via the circuit’s wires 36, and thus may be equated to a signal detector which has circuitry to measure/record the effects of the acoustic impedance of the system, therein an impedance measurement circuit; fig 1-3) comprising a diode, (diode 47; fig 3) a capacitor, and (capacitor 57; fig 3) an analog-to-digital converter electrically connected to a node between the diode and the capacitor (analog-to-digital converter 63; fig 3; see examiner’s annotation of Kren’s fig 3 denoting the node between the diode 47 and capacitor 57 which converter 63 is electrically connected to) PNG media_image1.png 468 440 media_image1.png Greyscale Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to import the signal processing means and structure taught by Kren into the signal detector and processing circuitry disclosed by Amschler, as Amschler is silent regarding the exact signal processing means it relies upon to measure its acoustic signal’s phase shift in determining its cavity length/distance and applying the known technique of Kren would advantageously provide means for measuring this phase shift with micron level accuracy, see col 1 line 51 to col 2 line 2. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FORREST DIPERT whose telephone number is (703)756-1704. The examiner can normally be reached M-F 8:30am-5pm eastern. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /FORREST BLAKE DIPERT/ Examiner, Art Unit 3783 /MICHAEL J TSAI/ Supervisory Patent Examiner, Art Unit 3783
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Prosecution Timeline

Apr 07, 2023
Application Filed
Dec 22, 2025
Non-Final Rejection — §103
Apr 02, 2026
Response Filed

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
46%
Grant Probability
99%
With Interview (+66.7%)
3y 6m
Median Time to Grant
Low
PTA Risk
Based on 35 resolved cases by this examiner. Grant probability derived from career allow rate.

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